Kornimate/medical-research-clean huggingface dataset:
usability and performance evaluation of the autolap system - a feasibility study

Conditions: General Laparoscopic Surgery Candidate; Bariatric Laparoscopic Surgery Candidate

Summary: the main objectives of this study are to evaluate the ease of use and performance of the autolap system compared to human camera holder during general and bariatric laparoscopic surgeries.


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form (icf). 2. patients over 18 years who were scheduled for elective laparoscopic cholecystectomy, nissen fundoplication, paraesophageal hernia and sleeve surgery procedures exclusion criteria: 1. extensive adhesions that will preclude routine laparoscopic surgical approach. 2. pregnancy 3. patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.

Keywords: laparoscopic cholecystectomy laparoscope holder nissen fundoplication paraesophageal hernia sleeve surgery
safety and efficacy of gadobutrol 1.0 molar (gadavist) in patients for central nervous system (cns) imaging

Conditions: Diagnostic Imaging; Central Nervous System Diseases

Summary: this study involves the use of magnetic resonance imaging (mri) contrast agents called gadobutrol (gadavist) injection and prohance injection. the purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking mr images of the brain and spine. the results of the mri with gadobutrol injection will be compared to the results of mr images taken without contrast and with the results of the mr images taken with prohance.

issues on safety will be addressed in adverse events section.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age * is referred for a contrast-enhanced mri of the cns based on current clinical symptoms or results of a previous imaging procedure * has been fully informed about the study, including provisions of the health insurance portability and accountability act (hipaa) as applicable, and has consented to participate exclusion criteria: * has any contraindication to the mri examinations or the use of gd-containing contrast agents * has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents * has severe cardiovascular disease (eg, known long qt syndrome, acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure new york heart association class iv) or acute stroke (\< 48 hours)- patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period

Keywords: patients referred for a contrast-enhanced mri of the cns cns imaging
lcar-m61sq in treatment of relapsed/refractory multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: a prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of lcar-m61sq in patients with relapsed/refractory multiple myeloma.

this study is a prospective, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of lcar-m61sq in patients with relapsed/refractory multiple myeloma. all subjects who meet the eligibility criteria will receive intravenous injection of lcar-m61sq cell injection. the study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Eligibility criteria:
inclusion criteria: * subjects voluntarily participate in clinical research; * age ≥18 years old; * eastern cooperative oncology group (ecog) score 0-2; * examination evidence of initial diagnosis of mm according to imwg diagnostic criteria; * measurable lesions were present; * subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (pd confirmed according to imwg criteria); * expected survival ≥3 months; * clinical laboratory values in the screening period meet criteria; exclusion criteria: * received previous therapy targeting gprc5d targets; * prior antineoplastic therapy and meet exclusion criteria (before apheresis); * subjects had waldenstrom macroglobulinemia, poems syndrome, or primary al amyloidosis at the time of screening. * subjects who were positive for any of hbsag, hbv dna, hcv-ab, hcv rna, and hiv-ab; * life-threatening allergic reactions, hypersensitivity reactions, or intolerance to car-t cell formulations or their excipients, including dmso, are known. * serious underlying diseases were present; * female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment. * also enrolled in other clinical studies.

Keywords: multiple myeloma relapsed/refractory multiple myeloma
intrinsic optical imaging study to map neocortical seizure in human epilepsy patients

Conditions: Epilepsy

Summary: the purpose of this study is to develop a technique for the intraoperative identification of human functional and epileptiform cortex using intrinsic signal imaging. the investigators propose that the ability to optically monitor neuronal activity in a large area of cortex in "real-time" will be a more sensitive and time-saving method than the electrical methods currently available. the applications of this technique will not only theoretically increase the safety and efficacy of many of neurosurgical procedures, but will be useful as an investigational tool to study human cortical physiology.

epilepsy is a disease affecting 1-2% of the population. currently, the only known cure for epilepsy is surgery, which is much more effective at eliminating seizures arising from the medial temporal lobe compared with the neocortex. the problem with neocortical epilepsy is that the population of neurons underlying each epileptiform discharge varies over time. in addition, the spatial relationship between interictal events and the ictal onset zones, which are critical in defining the region of epileptogenesis, is not well understood and essential to the surgical treatment of epilepsy. electrophysiological recording methods, although currently the "gold standard" in mapping epilepsy, are inadequate to address these questions based on restrictions due to volume conduction or sampling limitations. optical recording techniques can overcome many of these limitations by sampling large areas of cortex simultaneously to provide information about blood flow, metabolism and extracellular fluid shifts that are intimately related to excitatory and inhibitory neuronal activity. in fact, optical recordings may actually be more sensitive to certain aspects of epileptic activity than electrophysiologic recordings. the goal will be to translate these findings into the operating room and map human neocortical epilepsy with the same optical techniques. outcome following surgical resections to treat neocortical epilepsy will be correlated with the optical maps to determine the utility of intrinsic signal imaging in guiding brain surgery. these experiments will set the groundwork for implementing optical recordings in general clinical practice as a novel technique for mapping and predicting human seizures.

Eligibility criteria:
inclusion criteria: * medically intractable epilepsy * subjects undergoing neurosurgical operations requiring cortical mapping exclusion criteria: * subjects not undergoing neurosurgical operations requiring cortical mapping.

Keywords: epilepsy optical imaging optical mapping
effect of the stellate ganglion block on the retinal microcirculation

Conditions: OCTA; Severe Brain Injury; Subarachnoid Hemorrhage; Intracerebral Hemorrhage

Summary: surges in the sympathetic nervous system occur at the ictus of a variety of neurological critical illnesses including intracranial hemorrhage and ischemic stroke. it is hypothesized that these exaggerated increases in sympathetic nervous activity produce maladaptations that promote secondary brain injury. one of these possible mechanisms include diffuse vasospasm that cause cerebral ischemia. hence, methods to abrogate the sympathetic nervous system in this context are under active investigation. one possible method is the regional anesthesia technique of the stellate ganglion nerve block, which is ordinarily used for complex regional pain syndrome, but has been shown to reduce cerebral sympathetic activity and reduces vasospasm in patients with subarachnoid hemorrhage. however, its effect on the microcirculation is not clear. hence, we propose to study patients receiving the stellate ganglion nerve block as part of their standard medical care and to image their retinal microcirculation before and after the procedure using optical coherence tomography angiography (octa).


Eligibility criteria:
inclusion criteria: * age 18 years or older * patients receiving the stellate ganglion nerve block for an approved indication, e.g. complex regional pain syndrome exclusion criteria: * pregnancy * non-english speaking * temporary or permanent physical limitation that renders the patient unable to sit up and look inside octa device
expanded access for patients with pulmonary hypertension associated with pulmonary fibrosis

Conditions: Pulmonary Fibrosis; Pulmonary Hypertension

Summary: an expanded access program that provides inopulse treatment to patients with serious disease or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who are not able to participate in the sponsor's ongoing phase 3 rebuild clinical.


Eligibility criteria:
inclusion criteria: 1. signed informed consent form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments. 2. subjects greater than 18 years of age at the time of consent to study participation. 3. subjects with pulmonary hypertension associated with a disease or condition that are not eligible to participate in current ongoing clinical trials. 4. subjects are willing and considered in the judgement of the investigator able to use the inopulse device continuously for up to 24 hours per day. 5. female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). all female patients should take adequate precaution to avoid pregnancy. 6. subjects, in the opinion of the investigator that would benefit from ino treatment. exclusion criteria: 1. subjects who require treatment with riociguat. 2. clinical contraindication to inhaled nitric oxide, as deemed by the investigator. 3. subjects who require concurrent positive airway pressure (pap) or positive end expiratory pressure (peep). 4. concurrent use of benzocaine, dapsone, nitrites and nitrates (amyl nitrite, isosorbide, nitroglycerin, nitroprusside), phenazopyridine. or primaquine.

Keywords: pf pulmonary fibrosis pulmonary hypertension ph inhaled nitric oxide ino long term oxygen therapy ltot oxygen inopulse pulsed inhaled nitric oxide fild fibrotic interstitial lung disease portable pulsed inhaled nitric oxide
specialized substance abuse supervision (ssas) versus non-ssas recidivism rates among nebraska felony drug offenders

Conditions: Substance-related Disorders; Alcohol-related Disorders

Summary: this social science study hypothesizes that convicted felony drug offenders in nebraska who participated in specialized substance abuse supervision (ssas) as part of their probation or parole showed significantly better outcomes (specifically, less recidivism) at six months post-entrance to ssas compared to those who did not participate in ssas.

since march 2006, specialized substance abuse supervision (ssas) has been available at five sites in nebraska as an enhancement of probation and parole for felony drug offenders whose scores on initial screening instruments warrant such placement. ssas enhancements to traditional probation and parole include cognitive behavioral therapy (cbt) in groups; use of incentives; positive reinforcement; and motivational interviewing. records of probationers and parolees who participated in ssas starting anytime between march 1, 2006 and february 28, 2007 were studied to assess recidivism rates. recidivism for this study is defined as "an arrest and conviction on a new charge while on probation or parole." the records of a matched control group of non-ssas probationers and parolees who entered probation or parole during the same time period with similar drug felony offenses and similar screening scores were also studied. control group was also matched, as much as possible, with similar age group, demographic data, rural/urban residence, and level of felony offense. investigators performed a statistical analysis to determine recidivism rates at six months post-entrance to ssas (and for the control group, at six months post-entrance to probation or parole).

Eligibility criteria:
inclusion criteria: * convicted felony drug offender * sentenced in nebraska * probationer or parolee * entered probation or parole or ssas between march 1, 2006 and february 28, 2007 exclusion criteria: * convicted felony drug offender sentenced in nebraska starting probation or parole between march 1, 2006 and february 28, 2007 who does not match ssas probationers/parolees in terms of age, demographics, urban v. rural residence, and/or class of felony drug offense.

Keywords: specialized substance abuse supervision ssas substance use disorder felony drug offender probation parole cognitive behavioral therapy cbt
cellular and molecular analysis of synovial tissue of patients with arthritis

Conditions: Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Spondyloarthritis; Synovitis

Summary: this study aims to study the inflammatory response in various forms of arthritis.

arthritis, a significant heald burden is characterized by joint inflammation that severely impacts patients' quality of live. despite advancements in treatment, many individuals with conditions like rheumatoid arthritis (ra), osteoarthritis (oa), and spondyloarthritis (spa) do not achieve satisfactory outcomes, underscoring the need for more precise therapeutic strategies. the project aims to characterize the inflammatory response in various form of arthritis by collecting and analyzing synovial tissue-the connective tissue lining joints. biopsies will be collected through ultrasound-guided biopsies (ugsb), a minimally invasive and well-tolerated procedure. presence of immune and stromal cells in the tissue, their interactions, and their relationship to clinical symptoms are characterized by histological and molecular methods. by comparing these features across different forms of arthritis, the study aims to identify molecular pathways and biomarkers that distinguish these diseases and their subtypes. the study hopes to contribute to a broader understanding of arthritis pathophysiology, ultimately translating into novel therapeutic targets and tailored clinical strategies.

Eligibility criteria:
inclusion criteria: * age \>18 years * clinically relevant arthritis in one or more joints as assessed by the treating rheumatologist, including ra, spa, connective tissue disease and oa. exclusion criteria: * known allergies to local anesthetics * family history of bleeding, history of increased bleeding tendency or prolonged bleeding, current treatment with oral anticoagulants or platelet aggregation inhibitors; quick \ 37 sec * inability or insufficient knowledge of project language to understand the information given in the informed consent form

Keywords: ultrasound-guided synovial biopsies (ugsb) inflammatory response synovial biopsy
riluzole in fragile x syndrome

Conditions: Fragile X Syndrome

Summary: the purpose of this study is to investigate the effectiveness and tolerability of riluzole in adults with fragile x syndrome.

fragile x syndrome (fxs) represents the most common inherited form of intellectual disability. fxs is more common in males and the symptoms associated with the disorder are more marked in males. fxs is associated with characteristic physical features, behaviors, and comorbidities. those with fxs often suffer from behavioral difficulties that include anxiety-related symptoms (shyness, social phobia, obsessive-compulsive disorder (ocd) symptoms), attention deficit hyperactivity symptoms (overarousal, hyperactivity, distractibility, impulsivity) and aggressive/self-injurious behaviors. riluzole is approved by the fda for use in treating amyotrophic lateral sclerosis (als) in adults. recently, riluzole has been the subject of several open-label studies describing the use of the drug in treatment-resistant depression and ocd. given the overlap between repetitive behavior in fxs and symptoms of ocd, it is logical to study riluzole in fxs given the compound's promise in ameliorating treatment-refractory symptoms of ocd.

Eligibility criteria:
inclusion criteria: * males and females age 18 years or older. * confirmed molecular diagnosis of fragile x syndrome. * clinical global impression severity (cgi-s) score of 3 or greater. * significant interfering repetitive behavior as determined by the principal investigator. * must be in good health as determined by screening procedures including a detailed medical history, and complete physical and neurological examination. * dosing of concomitant medications during the study must remain stable. exclusion criteria: * pregnancy. * concomitant use of another glutamatergic agent (memantine, topiramate, amantadine, among others. * evidence of prior trial of riluzole and/or hypersensitivity/allergic reaction to riluzole. * abnormal baseline liver function tests at screen or by history; or complete blood count abnormalities at screen or by history.
positive angle kappa

Conditions: Aniridia

Summary: patients with aniridia have positive angle kappas.


Eligibility criteria:
inclusion criteria: * patients with aniridia only exclusion criteria: * poor va * pk, * k-pro

Keywords: aniridia positive angle kappa
the pathogenesis and prognostic factors of lymphoma

Conditions: Lymphoma; Hodgkin Lymphoma; Non-hodgkin Lymphoma

Summary: the aim of this study is to describe the clinical and genetic characteristics of chinese lymphoma patients, and to explore the relationship between those characteristics and phatogenesis.

lymphoma is a highly common malignant tumor in asia. this study aims to observe and describe the clinical and genetic charateristics of chinese lymphoma patients, and to explore the relationship between those charateristics and pathogenesis and prognostic factors in the real-world population. this study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. the medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility criteria:
inclusion criteria: * patients with pathological diagnosis of lymphoma (including hodgkin lymphoma and non-hodgkin lyphoma, eg. thrlbcl, dlbcl, mzl, cll/sll...) from 2007 to 2027. * patients with complete diagnostic, treatment and follow-up records. * fully comprehension and signature of the informed consent form (icf) for participation. exclusion criteria: * those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period. * severe mental illness. * patients deemed unsuitable for inclusion by the investigator.

Keywords: lymphoma hodgkin lymphoma non-hodgkin lymphoma thrlbcl dlbcl mzl cll/sll mcl wm
evaluation of safety, tolerability and preliminary efficacy of ehp-101 in diffuse cutaneous systemic sclerosis

Conditions: Diffuse Cutaneous Systemic Sclerosis

Summary: the purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ehp-101 in adult subjects with diffuse cutaneous systemic sclerosis (dcssc).

an interventional, double-blind, randomized, intracohort placebo-controlled design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of ehp-101 in 36 patients ≥ 18 and ≤ 74 years of age with documented dcssc. there is a screening period of 28 days, 84 days treatment period, and 28 days follow-up.

Eligibility criteria:
inclusion criteria: * patients male and female ≥18 years and ≤74 years at the time of consent; * american college of rheumatology/ european league against rheumatism 2013 criteria for ssc; dcssc (skin thickening on upper arms, upper legs, or trunk); * documented ssc for up to 6 years from the first non-raynaud's phenomenon with a total mrss of ≥15; * no new or increased doses of immunosuppressants medications within 3 months prior to screening; * effective method of contraception for participants and their partners. exclusion criteria: * severe or unstable systemic sclerosis (ssc) or ssc with end-stage organ failure; * patient with fvc \<60%; * history of clinically significant medical condition or concurrent medical therapies that would exclude the patient, preclude participation in the clinical trial, influence response to study product, or interfere with study assessments; * history of gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before visit 1; * any one of the following values for laboratory tests at screening: * haemoglobin \<9 g/dl; * neutrophils \<1.0 x 10\^9/l; * platelets \<75 x 10\^9/l; * estimated creatinine clearance \<50 ml/min according to the cockcroft-gault equation; * serum transaminases \>2.0 x upper normal limit; * total bilirubin ≥1.5 x upper limit of normal.

Keywords: scleroderma systemic sclerosis ehp-101 oral solution dcssc diffuse pathological processes connective tissue disease skin disease
prediction of 3d effect of brace in idiopathic scoliosis treatment using eos imaging system and "anatomic transfer".

Conditions: Idiopathic Scoliosis

Summary: in this study, the accuracy of a new numerical method is evaluated for predicting the 3d effect of brace on idiopathic scoliosis. this method results from the combination of several innovative technologies: the eos imaging system and the anatomical transfer developed by anatoscope. this is an essential step in validating a digital tool that can be used in routine clinical practice.

the whole process of brace production remains unchanged. in this study, the simulation software will not be used to influence the medical decision or the manufacture of the brace. in parallel with conventional production, anatomical transfer will be used in the deformed digital model of the trunk to simulate the effect of conventional brace on the spine. this modeling will be used to compare the correction of the conventional brace observed on the spine with eos imaging system, with that simulated by the software. eos tranfert study is a observationnal, prospective, monocentric, unrandomized and controlled study. this research doesn't modify care of the patient

Eligibility criteria:
inclusion criteria: * patients aged 9 to 15 years; * with idiopathic scoliosis (left lumbar and / or right chest); * with moderate scoliosis: cobb angle evaluated between 15 ° and 35 °; * requiring brace placement or renewal; * having signed a non-objection form * affiliated with, or receiving, social security exclusion criteria: * patient/parents who refuse to sign a non-objectiont form * with unstable medical condition * person deprived of liberty by judicial or administrative decision * person under legal protection or unable to express their consent * person hospitalized for psychiatric care

Keywords: 3d analysis brace eos imagind system anatomical transfer